Inguinal Hernia, IndirectNCT03203343
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair
A study testing Operation - PIRS and Operation - MARCY in people with Inguinal Hernia, Indirect and Children, Only, run by University Hospital of Split at 1 site in Croatia.
Trial summary
Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Read more about this study
- Who is it for?
- Ages 3 to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Indirect, Children, Only, Inflammatory Response
- What is being tested?
- Operation - PIRS and Operation - MARCY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCroatia
- Study dates
- 1 May 2017to 25 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- male children with inguinal hernia at age of 3 to 7
- one-sided inguinal hernia
Who cannot join
- Female children
- recurrent hernia
- bilateral hernia
- age less than 3 y, more than 7 y
- any general inflammatory process, illness
- intraoperative complications which may interfere with inflammatory stress response
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University hospital of Split
Split, Split-Dalmatia County, 21000
About this study
Official title: Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.
Read the detailed description
Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α).
Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.
- Conditions
- Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha
- Being tested
- Operation - PIRS, Operation - MARCY
- Keywords
- Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation - PIRSProcedure or surgery
Operation by its known design for PIRS group
Operation - MARCYProcedure or surgery
Operation by its known design for MARCY group
| Study group | Role | What they receive |
|---|---|---|
| PIRS group | Active comparator | Patients operated laparoscopically - PIRS technique Receives: Procedure: Operation - PIRS |
| Marcy group | Active comparator | Patients operated by open modified Marcy technique Receives: Procedure: Operation - MARCY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory stress response (IL6)
measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Measured: 3 measurements: preoperative, 24 hours after and 6 days after surgery
Change in inflammatory stress response (CRP)
measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below
Measured: 3 measurements: preoperative, 24 hours after and 6 days after surgery
Change in inflammatory stress response (TNF alpha)
measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Measured: 3 measurements: preoperative, 24 hours after and 6 days after surgery
Change in inflammatory stress response (Leukocytes WBC)
measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below
Measured: 3 measurements: preoperative, 24 hours after and 6 days after surgery
Secondary outcomes (2)
Subjective pain assessment
Visual analog pain scale
Measured: 24 hours after and 6 days after surgery
Subjective pain assessment
Visual analog pain scale
Measured: 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 May 2017
- Primary completion1 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia, IndirectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miro Jukić, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203343
- Sponsor's protocol ID
- University hospital of Split
- Status last verified
- Dec 2018
- First submitted
- 16 Jun 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing
Publications
Jukic M, Pogorelic Z, Supe-Domic D, Jeroncic A. Comparison of inflammatory stress response between laparoscopic and open approach for pediatric inguinal hernia repair in children. Surg Endosc. 2019 Oct;33(10):3243-3250. doi: 10.1007/s00464-018-06611-y. Epub 2018 Dec 3.
PubMed 30511312
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03203343
- Acronym / sponsor ID
- University hospital of Split
- Conditions
- Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha
- Keywords
- Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.
Detailed description
Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α).
Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIRS group | Active comparator | Procedure: Operation - PIRSPatients operated laparoscopically - PIRS technique |
| Marcy group | Active comparator | Procedure: Operation - MARCYPatients operated by open modified Marcy technique |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male children with inguinal hernia at age of 3 to 7
- one-sided inguinal hernia
Key exclusion criteria (6 listed)
- Female children
- recurrent hernia
- bilateral hernia
- age less than 3 y, more than 7 y
- any general inflammatory process, illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operation - PIRSOperation by its known design for PIRS group | Procedure or surgery | PIRS group |
| Operation - MARCYOperation by its known design for MARCY group | Procedure or surgery | Marcy group |
Primary outcome
Change in inflammatory stress response (IL6)
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Change in inflammatory stress response (CRP)
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below
Change in inflammatory stress response (TNF alpha)
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Change in inflammatory stress response (Leukocytes WBC)
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below
2 secondary outcomes
Subjective pain assessment
Time frame: 24 hours after and 6 days after surgery
Subjective pain assessment
Time frame: 6 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 30511312Jukic M, Pogorelic Z, Supe-Domic D, Jeroncic A. Comparison of inflammatory stress response between laparoscopic and open approach for pediatric inguinal hernia repair in children. Surg Endosc. 2019 Oct;33(10):3243-3250. doi: 10.1007/s00464-018-06611-y. Epub 2018 Dec 3.
- Individual participant dataSharing planned: Yes. Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing
Related trials for Inguinal Hernia, Indirect
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation - PIRS and Operation - MARCY in people with Inguinal Hernia, Indirect and Children, Only, run by University Hospital of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory stress response (IL6) (time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.